Sterile Solution-Filled Container Production Through Separate Sterilization

Resolve Bottlenecks,
Find Innovative SolutionsGenerate Solutions

Solution Overview

Problem

Conventional methods for manufacturing sterile solution-filled containers, such as terminal sterilization and aseptic filling, are costly, inefficient, and prone to contamination, with terminal sterilization degrading formulations and aseptic processes requiring expensive equipment and stringent environmental controls.

Innovation Solution

A method and system for producing sterile solution-filled containers using a flexible filling platform that includes a disposable cartridge with a filter assembly and a filling machine, which automates the process to ensure sterility and safety without specialized barrier systems, utilizing a dual pump configuration and aseptic cartridge connectors to fill and seal containers efficiently.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If terminal sterilization is used to sterilize solution-filled bags, then sterility is achieved, but the solution formulation is degraded and becomes unstable

Engineering Contradiction:

ImprovesterilityVSAvoidsolution formulation stability

Core Design Contradiction:

ReliabilityVSStability of the object's composition

Solution Approach 1:

The patent applies preliminary sterilization by sterilizing the bags and solution separately before filling. The bags are sterilized through exposure to radiation (e.g., gamma radiation) and the solution is sterilized through filtration before the filling process, thereby achieving sterility without subjecting the formulated solution to degrading heat sterilization conditions

Inventive Principle:

Principle #10Preliminary action

2Reliability

If aseptic filling process is used to prevent contamination, then sterility is maintained, but expensive equipment and stringent environmental controls are required

Engineering Contradiction:

ImprovesterilityVSAvoidequipment and environmental control complexity

Core Design Contradiction:

ReliabilityVSDevice complexity

Solution Approach 1:

The patent segments the sterilization process from the filling process. The bags are sterilized separately through radiation exposure, and the solution is sterilized separately through filtration, allowing the filling to occur without requiring the entire filling environment to be sterile. This reduces the complexity of environmental controls and equipment requirements

Inventive Principle:

Principle #1Segmentation

Solution Approach 2:

The patent introduces sterile filters as an intermediary component. The filters serve as a barrier that allows the solution to be sterilized without requiring the filling environment to be sterile, thereby simplifying the overall system complexity while maintaining sterility

Inventive Principle:

Principle #24Intermediary (Mediator)

3Reliability

If terminal sterilization is used to sterilize bags of solution, then sterility is achieved, but non-viable contamination is not eliminated

Engineering Contradiction:

ImprovesterilityVSAvoidnon-viable contamination

Core Design Contradiction:

ReliabilityVSObject-affected harmful factors

Solution Approach 1:

The patent changes the sterilization parameters by using radiation sterilization instead of heat sterilization. Radiation sterilization effectively eliminates both viable and non-viable contaminants without degrading the solution formulation, thereby achieving superior sterility assurance while preserving solution stability

Inventive Principle:

Principle #35Parameter changes

4Productivity

If centralized manufacturing facilities are used for terminal sterilization, then large batches can be produced, but capital expenditure and space requirements increase

Engineering Contradiction:

Improvebatch production capacityVSAvoidcapital expenditure and space requirements

Core Design Contradiction:

ProductivityVSDevice complexity

Solution Approach 1:

The patent employs disposable sterile bags that can be sterilized through radiation exposure. These single-use sterile bags eliminate the need for expensive, large-scale terminal sterilization facilities, thereby reducing capital expenditure and space requirements while maintaining the ability to produce large batches through distributed manufacturing

Inventive Principle:

Principle #27Cheap short-living objects (Disposable)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The system ensures high efficiency and sterility of the filling process, reducing costs and contamination risks by automating the production of sterile containers, allowing for flexible and scalable manufacturing without the need for isolators or RABS, and ensuring the integrity of the solution formulation.

Implementation Method 1

The cartridge may include a filter assembly, a connection line in fluid communication with the filter assembly

Methodology Applied

Scientific EffectFiltration: Filter (physical)

Data Source

PatentUS20250289607A1Method and system for producing sterile solution filled containers

Publication Date: 2025.09.18 BAXTER INT INC

AI summary

A cartridge assembly for a filling machine includes a plurality of containers. Each container includes a volume and a stem connected to the volume. A connection line grid is in fluid communication with each stem of the plurality of containers. The connection line grid includes a first row connected to one or more containers of the plurality of containers and a second row connected to one or more containers of the plurality of containers. A filter assembly is coupled to the connection line grid.